MAUDE Adverse Event Report: BONESUPPORT AB CERAMENT BONE VOID FILLER; CALCIUM SALT BONE VOID FILLER

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/01/2015

Event Type  Injury  

Manufacturer Narrative

Tibia plateau fracture treated with osteosynthesis and filling of subchondral defect with cerament bvf under fluoroscopy and arthroscopic visual control.No leakage was noticed during the primary operation.Because of continuing pain a ct scan was carried two months postoperatively.The ct scan showed a small fragment placed in a defect just above the joint line requiring arthroscopic removal.Conclusion: possibly the intra-articular fragment was a piece of cerament, alternatively a bone/cartilage fragment.Assuming the fragment was a piece of cerament, whether it was leakage during the operation or migration afterwards cannot be decided.With the available information no further action is required at present.

Event Description

Ct scan due to persisting pain, detection of intraarticular cerament-fragment, consecutive arthroscopic removal.

• Brand Name: CERAMENT BONE VOID FILLER
• Type of Device: CALCIUM SALT BONE VOID FILLER
• Manufacturer (Section D): BONESUPPORT AB; scheelevägen 19; ideon science park; lund, skane SE-22 3 70; SW SE-223 70
• Manufacturer (Section G): BONESUPPORT AB; scheelvagen 19; ideon science park; lund, skane SE-22 3 70; SW SE-223 70
• Manufacturer Contact: gabriella gaerds ; scheelevägen 19; ideon science park; lund, skane SE-22-3 70 ; SW SE-223 70 ; 46 2865358
• MDR Report Key: 6269442
• MDR Text Key: 65505295
• Report Number: 3005304945-2016-00003
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• PMA/PMN Number: K073316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: N/A
• Device Catalogue Number: A0210-10
• Device Lot Number: MLOT0148
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR